Self shortening fastener

ABSTRACT

Disclosed is a fastener that can be mounted to a bone of a patient and can foreshorten and swell of a desired period of time. The fastener can include a head portion and a body portion extending from the head portion. At least one of the head portion and the body portion has a first width that changes to a second width greater than the first width and collectively the head portion and the body portion have a first length that changes to a second length shorter than the first length upon the head portion and the body portion being exposed to a temperature below a glass transition temperature of a polymeric material forming the head portion and the body portion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a divisional of U.S. patent application Ser.No. 11/146,433 filed Jun. 6, 2005 and entitled “SELF FORESHORTENINGFASTENER,” which claims the benefit of and priority to U.S. ProvisionalPatent Application Ser. No. 60/577,640 filed Jun. 7, 2004, and entitled“Self Foreshortening Screw”, with Randolf Von Oepen as inventor, thedisclosures of which are incorporated in their entireties herein byreference. Additionally, this United States patent applicationcross-references other United States patent applications filedsimultaneously with U.S. patent application Ser. No. 11/146,433 on Jun.6, 2005, entitled “Fastener Having Torque Optimized Head” with RandolfVon Oepen as inventor, U.S. patent application Ser. No. 11/145,692, and“Polymeric Plate Bendable Without Thermal Energy and Methods ofManufacture” with Randolf Von Oepen and Alexander Tschakaloff asinventors, U.S. patent application Ser. No. 11/146,454. The disclosureof each of the foregoing cross-referenced United States patentapplications is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

This application relates generally to fasteners. More specifically, thepresent invention relates to a medical fastener that can shorten inlength and increase in width over time.

2. The Relevant Technology

Bones are a vital skeletal feature and provide the frame and structuralsupport for holding associated muscles and other tissue. Additionally,bones, such as the skull bones and ribs, are responsible for protectingvital organs such as the brain, heart lungs, and the like. While bonesare structurally strong, they tend to break for various reasons whensubjected to excessive forces. Usually, the healing process includes amedical professional aligning the bones on each side of the break sothat the regenerated bone material provides a structurally sound mendedbone.

In addition to aligning the bone, various stabilizing techniques havebeen used to retain the broken bone in proper alignment during thehealing process. Traditionally, casts have been used to stabilize minorbreaks that do not need structural reinforcement at the bone. On theother hand, some complicated fractures or breaks can be susceptible tofalling out of alignment during the healing process. As such, plates andfasteners can be used to stabilize the broken bones or fix bonestructures. Use of these kinds of structural reinforcement systemsduring healing have been known to provide bone regeneration and mending.

Due to excellent strength and stability profiles, metallic fasteners andplates have dominated the market for reinforcing breaks or fracturesduring healing. The most accepted metallic fasteners and plates arebiocompatible titanium and/or titanium alloys; however, other types ofmetallic materials have also been used. Nevertheless, metallic fastenersand plates can be problematic and have some disadvantages

One disadvantage of implanted metallic fasteners and plates arises frombeing treated as a foreign body, which sometimes requires the fastenersand plates to be removed. This can occur even if the metallic fastenerand plate system is initially well tolerated. As such, the subsequentsurgery to remove the metallic fastener and plate system can causeadditional trauma to the patient, and adds additional costs to thehealth care system; especially when the patient has to be hospitalizedafter the procedure. Additionally, if the metallic fastener and platesystem includes an iron component, the irons released from the metallicimplant may be found in other organs, which can cause long-termproblems.

Another major disadvantage of metallic fastener and plate systems arisesfrom being much stronger than the bone being supported. As such, abroken bone that is fixed with a metallic fastener and plate system maynot experience proper loading during the healing process. This isbecause the metallic repair system can carry a large portion of the loadthat is normally carried by the bone. As a result, the bone can becomeweaker over time when the metallic repair system is left in place.Accordingly, after removal of the metallic repair system, the repairedbone may be susceptible to fracturing around the region that waspreviously supported. Even though the metallic repair system providesstructural reinforcement to the healing bone, the bone may developdecreased stability.

Additional problems arise because bone is a living structure. When ametallic fastener is drilled into bone, the compact pressure thatresults, for example, on a plate, is very high and leads to very goodinitial stability. Under the stress exerted by the fastener and theplate, the bone will change its structure and the fastener may loosenover time. This causes significant problems with maintaining bonealignment during bone regeneration because the plate can move as thefastener loosens.

BRIEF SUMMARY OF THE INVENTION

The present invention overcomes the problems described above byproviding a fastener that mounts securely within bone over time. Thepresent invention relates to a biodegradable polymer fastener thatforeshortens in length and swells in diameter over time to securelymount within bone.

In one configuration, the fastener includes a head portion and a bodyportion extending from the head portion. The head portion and the bodyportion collectively have a first length that changes to a second lengthshorter than the first length upon the head portion and the body portionbeing exposed to a body temperature below a glass transition temperatureof a polymeric material forming the head portion and the body portion.Alternatively, the polymeric material can have a glass transitiontemperature that is lower than normal body temperature, but a glasstransition temperature higher than the normal body temperature canprovide increased stability. The shortening in length can occur beforethe fastener begins to degrade. Therefore, the width of at least one ofthe head portion and the body portion can increases in diameter or swellupon the head portion and the body portion being exposed to thetemperature below the glass transition temperature of the polymericmaterial.

According to one aspect, the glass transition temperature is higher thana temperature of a patient's body. For instance, the glass transitiontemperature can be between about 37 degrees Celsius and about 60 degreesCelsius.

According to another aspect, the polymeric materials can bebiodegradable and have a polymer molecule orientation so that theincrease in width of at least one of the head portion and the bodyportion is greater than about 2% after the head portion and said thebody portion are immersed within a fluid maintained at about 37 degreesCelsius for 10 days. In other configurations, the increase in width canbe from about 3% to about 6% or from about 4% to about 5%.

According to another aspect, the polymeric material forming the fastenercan have a polymer molecule orientation that includes less than about40% of the polymer molecules being oriented in substantially onedirection. In another configuration, about 10% to about 30% or thepolymer molecules can be oriented in substantially one direction, orabout 15% to 25% oriented in substantially one direction.

In another configuration, a method of manufacturing an implantablefastener is provided. The method can include injection molding abiocompatible polymeric composition into a polymeric body within aninjection mold cavity of an injection mold. At least a portion of thepolymeric body is configured to be an implantable fastener. Followinginjection molding, the method can include removing the polymeric bodyfrom the injection mold, wherein the polymeric body has an amount ofpolymeric molecules oriented in substantially a first direction so thatthe polymeric body foreshortens and swells at a temperature below aglass transition temperature of the biocompatible polymeric composition.

The method can also include passing the polymeric composition through aninlet in a master mold that is configured to orientate macromolecules ofthe biocompatible polymeric composition in substantially a firstdirection. The inlet can impart a shear stress to the polymericcomposition to orientate macromolecules of the biocompatible polymericcomposition in substantially the first direction generally parallel to alongitudinal axis of the polymeric body. The inlet can have across-sectional length (diameter) from about 10% to about 60% of anaverage cross-sectional length (diameter) of said injection mold cavityor runner feeding the inlet. In other configurations the inlet diameteror cross-sectional length can range from about 20% to about 50% or fromabout 30% to about 40% of the mold cavity average cross-sectional length(diameter) or runner cross-sectional length (diameter). As used herein,the term “cross-sectional length” is meant to refer to the diameter of acircular cross-sectional area or width of polygonal cross-sectionalarea.

According to another aspect, the injection mold can include a mastermold and one or more sub-molds. Each of the one or more sub-molds caninclude the injection mold cavity and the type of sub-mold used with themaster mold can be varied based upon the number and type of fastener tobe made.

According to another aspect, the method can further include a least oneof (i) mixing the polymeric composition in a mixer, (ii) extruding thepolymeric composition as a thermoplastic extrudate, (iii) heating thepolymeric composition before being introduced into the injection moldcavity, (iv) introducing the polymeric composition into the injectionmold cavity under pressure, (v) cooling the polymeric body in theinjection mold cavity, (vi) separating the implantable fastener form thepolymeric body, or (vii) finishing the implantable fastener.

These and other objects and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 illustrates a perspective view of a fastener according to thepresent invention;

FIG. 2 schematically illustrates one process for manufacturing thefastener according to the present invention;

FIG. 3 illustrates one configuration of a master mold usable with theprocess for manufacturing the fastener of FIG. 2; and

FIG. 4 schematically represents the illustrative methods steps formanufacturing the fastener according to the present invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The present invention generally relates to a fastener that mountstightly and securely within bone as the bone changes its structure underthe stress applied by the fastener. The present invention also relatesto a fastener made of a biodegradable polymer that shortens in lengthand swells in diameter to maintain a tight and secure fit within boneduring the time when the bone regenerates and degrades following repairof the bone.

Turning to FIG. 1, illustrated is a fastener 10 according to one aspectof the present invention. The fastener 10, such as a screw, pin, boneanchor, suture material, bone pins, meniscus repair systems, clamps orthe like, can be used during a medical procedure to aid with positioningbone or fixing other medical devices to patient bone. A driver (notshown) can be used either alone or in combination with an electric drillor other device for rotating the driver to mount the fastener 10 intothe bone. Additional information regarding the driver and the manner ofmounting the fastener 10 into the bone can be found in co-pending U.S.patent application Ser. No. ______, entitled “Fastener Having TorqueOptimized Head”, filed Jun. 6, 2005 (Attorney Docket No. 16406.3.1),which is incorporated herein by this reference.

The illustrated fastener 10 can include a fastener head or head portion12 and a body portion 14 extending from the head portion 12. The headportion 12 can include a recess 16 to receive the driver (not shown),while a thread 18, such as a raised helical rib, winds around the bodyportion 14 and can mount or engage with a patient's bone or tissue whenthe fastener 10 is driven into the bone or tissue. Since the headportion 12 has a diameter greater than the body portion 14, the headportion 12 prevents excessive mounting of the fastener 10 to the bone ofa patient, i.e., the head portion 12 prevents the fastener 10 from beingdriven too deeply into the bone or passing through a mounting hole in aplate mountable to the patient's bone.

With continuing reference to FIG. 1, the head portion 12 can have acurved portion 22 and a generally tapered portion 24. It will beunderstood, however, that each of the curved portion 22 and the taperedportion 24 can have other configurations. For example either or both ofthe curved portion 22 and the tapered portion 24 can be planar.Similarly, although the head portion 12 is illustrated as having agenerally circular peripheral edge, one skilled in the art canappreciate that the peripheral edge can be polygonal, oval, or any otherconfiguration.

Similarly, while the body portion 14 is illustrated as having agenerally uniform cross-section along its length, it will be understoodthat the body portion 14 can have a tapered configuration or some otherconfiguration so long as the body portion 14 can engage with thepatient's bone or other structure within which the fastener 10 isdriven. In additional, it will be understood that the head portion 12and the body portion 14 can have various other configuration that aretypically associated with a screw and more generally a threadedfastener, i.e., a fastener including one or more threads to aid inmounting the fastener to a structure.

The thread 18 of the body portion 14 can extend from a first end 30toward a second tapered end 32. Alternatively, the body portion 14 canextend from a first end 30 to second end 32, wherein the first endand/or the second end can be of a constant dimension or tapered.Interrupting the thread 18 can be a channel 34 having an open end at thesecond tapered end 32. This channel 34 provides clearance at the end ofthe fastener 10 to collect particles, such as scale of bone, particlesand blood, which are within a hole, optionally tapped, receiving thefastener 10. By collecting the scale of bone, particles and blood, thechannel 34 eliminates the possibility that scale of bone, particles andblood can press between the fastener 10 and the hole's wall or threadsand prevent the fastener or screw from being driven into the hole.Including the channel 34 can reduce the frictional contact between thefastener 10 and the hole's wall or threads, thereby making it easier tomount the fastener 10 to the patient's bone.

Although the description of the present invention will be directedgenerally to the shortening and swelling of the fastener 10 for medicalprocedures, it will be understood by those skilled in the art that theshortening and swelling features of the present invention can apply toother situations and other types of fasteners. Consequently, thepresently described invention may be used in other situations outsidethe medical arts and other types of fasteners.

To alleviate many of the problems associated with existing metallicfasteners, such as the loosening of a metallic fastener in bone overtime, the above-described fastener 10 can be manufactured from abiodegradable polymer that foreshortens and swells in diameter over timeto maintain a tight and secure fit within bone. The fastener 10increases in diameter over time to tightly mount to the bone as thestressed bone changes its structure. The fastener 10 can, therefore,maintain desired stability for a period of time longer than existingmetallic fasteners or screws. Optionally, the fastener 10 can bemanufactured from a polymeric composition comprised of biodegradable,inert, and/or natural polymers.

To achieve the desired foreshortening and swelling, the fastener 10 canbe fabricated from a polymer having a high degree of polymer chainorientation, where polymer chain orientation describes the amount ofpolymer macromolecules that are aligned in one direction. This type ofpolymer can be referred to as a high orientation polymer. With thepolymer being highly orientated, the fastener 10 would be expected tomaintain its dimensions when the fastener 10 is exposed to temperaturesbelow its glass transition temperature, or the temperature above whichthe polymer changes from a hard or brittle condition to a flexible andelastomeric condition. It has been found, however, that whenmanufactured from a highly orientated polymer the fastener 10 relaxes attemperatures of approximately 37 degrees Celsius (the typicallytemperature within a patient's body), even if the glass transitiontemperature is much greater, such as above 50 degrees Celsius or betweenabout 45 degrees Celsius to about 60 degrees Celsius. This relaxingcauses the fastener 10 to shorten or shrink in the direction of theorientation of the polymer macromolecules. Aligning the polymermacromolecules with the longitudinal axis of the fastener 10 results inthe fastener 10 shortening or shrinking in length. Since the totalvolume of the fastener 10 remains the same, at least before the fastener10 begins to biodegrade, the fastener 10 swells as it shortens orshrinks This swelling maintains the fastener 10 securely within the boneas the bone changes structure under the stress applied by the fastener10.

The degree of shortening and swelling can be chosen by selectingparticular materials and the process used to create the fastener 10. Forinstance, the fastener 10 can be configured and fabricated to have lessthan about 6% or 3% shrinkage in length over a period of 10 days afterbeing placed in a 37° C. bath. Alternatively, the fastener 10 can beconfigured to shrink greater than 2% in length under the sameconditions. Moreover, the fastener can swell from about 0.5% to about10% of an original dimension under the same conditions. It will beunderstood that other degrees of shrinkage and/or swelling can beappropriate and higher or lower than the identified 3% and 10%.

As described, the shrinkage and/or swelling of the structural elementafter implantation in a subject can be highly depended on the method ofmanufacturing, but also of the material. It has been observed that pureamorphous materials have the tendency to shrink more than materialswhich or by its nature crystalline or semi-crystalline. Thus, amorphousmaterials can have shrinkage from about 5% to about 50%, or from about10% to about 30% in other configurations.

Additionally, crystalline or semi-crystalline materials can have ashrink in length from about 0.5% to about 15%, or about 1% to about 10%in other configurations. Accordingly, the swelling in width can be fromabout 0.5% to about 20%, or from about 1% to about 15% in otherconfigurations. Also, it should be understood that the swelling andforeshortening do not have to be uniform over the width or length of thescrew or fastener. Moreover, by varying the dimensions of the fastener(i.e., tapering) the shrinkage and swelling can be adjusted accordingly.

Various types of polymers can be employed in preparing the fastener 10in accordance with the present invention. The polymers can include awide range of biocompatible materials that can be implanted within bodyof a living animal, such as a human, dog, cat, horse, cow, and the like.Additionally, the polymers can be combined and blended in order toachieve compositions that have high initial strengths, shortens andwidens over time, and can degrade within a living body over time.

In one embodiment, a polymer composition for use in injection moldingthe fastener 10 can include at least one biodegradable polymer. Forexample, the biodegradable polymer composition can include at least oneof poly(alpha-hydroxy esters), polylactic acids, polylactides,poly-L-lactide, poly-DL-lactide, poly-L-lactide-co-DL-lactide,polyglycolic acids, polyglycolide, polylactic-co-glycolic acids,polyglycolide-co-lactide, polyglycolide-co-DL-lactide,polyglycolide-co-L-lactide, polyanhydrides, polyanhydride-co-imides,polyesters, polyorthoesters, polycaprolactones, polyesters,polyanydrides, polyphosphazenes, polyester amides, polyester urethanes,polycarbonates, polytrimethylene carbonates,polyglycolide-co-trimethylene carbonates, poly(PBA-carbonates),polyfumarates, polypropylene fumarate, poly(p-dioxanone),polyhydroxyalkanoates, polyamino acids, poly-L-tyrosines,poly(beta-hydroxybutyrate), polyhydroxybutyrate-hydroxyvaleric acids,combinations thereof, or the like. Additionally, these polymers can beused at a wide range of molecular weights, which can range from lessthan about 25,000 MW to over 1,000,000 MW. More particularly, themolecular weight can vary depending on the type of polymer, initialstrength, shortening and swelling rate, degradation rate, and the like.Additional information on the tensile strength, tensile modulus,flexural modulus, and elongations at yield and at break of variousbiocompatible and biodegradable polymers can be found with Engelberg andKohn; Physico-mechanical Properties of Degradable Polymers Used inMedical Applications: A Comparative Study; Biomaterials; 1991;12:292-304, which is incorporated herein by reference.

In one embodiment, a polymer composition for use in injection moldingthe fastener can include at least one inert polymer. For example, theinert polymer can include at least one of high-density polyethylenes,ultra-high-density polyethylenes, low-density polyethylenes,polypropylenes, polyacrylates, polymethylmethacrylates,polyethylmethacrylates, polysulfones, polyetheretherketones,polytetrafluoroethylenes, polyurethanes, polystyrenes,polystyrene-co-butadienes, epoxies, and the like. Such inert polymerscan be used at a wide range of molecular weights in order to impartvarious mechanical strengths and shortening and swelling rate to thefastener 10.

In one embodiment, the polymer composition for use in injection moldinga biocompatible fastener 10 can include at least one natural polymerthat can be derived from a natural source. Natural polymers can includepolysaccharides, proteins, and the like. Examples of some suitablepolysaccharides include methylhydroxyethylcellulose,hydroxymethylethylcellulose, carboxymethylcellulose, methylcellulose,ethylcellulose, hydroxyethylcellulose, hydroxyethylpropylcellulose,amylopectin, amylose, seagel, starches, starch acetates, starchhydroxyethyl ethers, ionic starches, long-chain alkylstarches, dextrins,amine starches, phosphate starches, and dialdehyde starches, alginicacid, phycocolloids, agar, gum arabic, guar gum, locust bean gum, gumkaraya, gum tragacanth, and the like. Examples of some proteinaceousmaterials include collagens, caseins, and the like. Moreover, thesenatural polymers can also impart biodegradable characteristics to thefastener 10.

In one embodiment, the biodegradable polymers can be reinforced withfibers comprised of magnesium, wherein such fibers can significantstrength the fastener. For example, short fibers, which are added to thepolymer during the injection molding process, can be oriented in thedirection of the flow so as to significantly improve the mechanicalproperties. Additionally, the magnesium fibers can be pretreated withcorona plasma or other well-known method to improve the interfacebetween the polymers and fiber. Since pure magnesium can be highlyreactive with water or body fluids, the polymer matrix can act as ashield and protect against fast degradation and magnesium reactions. Itcan also be understood that optionally the fastener can be formedcompletely from magnesium and subsequently coated with a polymer coatingto shield and protect against fast degradation.

In one embodiment, short fibers of biodegradable micro or nano-poroussilicon materials, biodegradable ceramics, organic materials can beadded to the polymer and fastener. The short fibers, which are added tothe polymer during the injection molding process, can be oriented in thedirection of the flow and significantly improve the mechanicalproperties of the resulting fastener. Optionally, these degradablefibers can be pretreated with corona plasma or other well-known methodto improve the interface between the polymer matrix and the fiber. Also,the rate of fiber biodegradation can be slowed by being encapsulatedwithin the polymer matrix.

The addition of fibers into the fastener can improve many of themechanical and/or strength characteristics. In part, this can arise fromthe nature of the fibers, and/or being oriented with the polymermolecules. For example, the fibers can increase the Young's modulus andincrease the strength.

In another embodiment, the fastener can be fabricated from magnesium,biodegradable micro or nano-porous silicon materials, biodegradableceramics, or organic materials. Optionally, the fastener made from oneor more of these materials and ceramics can be coated or covered with apolymer or polymer matrix.

In yet another embodiment, the biodegradable polymers of the fastenercan be admixed with a drug for being delivered into the body afterimplantation. This can include mixing a drug into the polymercomposition before being injection molded, or applying a drug-containingpolymeric coating onto the fastener. In any event, a portion of thefastener, either the bulk biodegradable polymer or a biodegradablecoating can be configured to deliver drugs into the body after beingimplanted. Accordingly, any drug can be included into the fastener,including but not limited to, analgesics, anti-inflammatory,anti-microbial, and like drugs.

In one embodiment, the biodegradable polymers, inert polymers, naturalpolymers, magnesium fibers, and/or porous silicon fibers can be preparedinto a polymeric blend that is comprised of different types of polymersand materials. As such, a polymeric blend can be configured to achieveinjection moldability, polymer molecule orientation, high initialstrength, and desired shortening and swelling rates. Moreover, thebiodegradable polymers and/or natural polymers can be blended in orderto achieve the fastener 10 that can degrade over time after beingimplanted.

In order to achieve the desired swelling and foreshortening, the polymermolecules can be oriented within the fastener 10 to have a desiredamount of orientation. For example, when the polymer is biodegradable,such orientation includes less than about 40% of the polymer moleculesoriented in substantially one direction. In other configurations, theorientation can be from about 10% to about 30% oriented in substantiallyone direction, or from about 15% to 25% oriented in one direction.However, when other polymers or additives are included, variations inthe amount of orientation can be achieved and still retain theforeshortening characteristic.

In one embodiment, it can be preferred to prepare the fastener with abiodegradable polymer and another material such as an inert polymer,natural polymer, magnesium fiber, and/or silicon fiber. In one aspect,this can be beneficial to allow biodegradability over time and stillretain some structural support after the degradable portion has beendepleted. As such, this can be favorable for complex bonereconstructions that may need some long-term support. That is, aninitially high amount of support can be provided that decreases overtime until a final amount of support is obtained, which allows the boneto reform and strengthen as the biodegradable portion is depleted.Alternatively, additional biodegradable materials can enhance thebiodegradability of the fastener. For example, the biodegradable polymerto other material ratio can range from about 10 to about 1, from about 8to about 4 in other configurations, from about 6 to about 4 in yet otherconfigurations, and vice versa depending on the characteristic desired.

Moreover, an embodiment of the fastener 10 can be configured to shrinkin a water bath maintained at about 37° C. As such, the fastener can beconfigured to have a dimension, such as length, that foreshortensgreater than about 1% of its original dimension in a period of 10 days,greater than about 2%, or greater than 4% in other configurations.Additionally, the fastener 10 can be configured to swell in width to begreater than about 2% of its original dimension in a period of 10 days,greater than about 3%, or greater than 5% in other configurations.

In one embodiment, a fabrication system and process can be employed toprepare the fastener 10 (FIG. 1) having features in accordance with thepresent invention, i.e., impart the desired amount of polymer moleculeorientation. Such a fabrication system can include the use of aninjection mold configured to prepare the fastener 10 (FIG. 1) having thecharacteristics described herein. The injection molding process canimpart a shear stress to the polymer molecules that results in thedesired amount of orientation, which is usually in the direction of theflow within a mold of the injection molding system. The process ofinjection molding is a controllable process that results in the fastener10 (FIG. 1) having the directional molecular orientation to achieve thedesired strength and flexibility so that it will not break, fracture, orfatigue during use and will shorten and swell when mounted within bone.

Common elements of an injection molding system can include, but notlimited to, the runners, runner network, flow dividers, cold wells, gateregions, gates, and a mold having a mold cavity. By varying theconfiguration of each of these and manipulating or changing the moldcavity orientation, vents, mold temperature, polymer composition andtemperature, and flow or injection rates of an injection mold system thedesired amount of polymer molecule orientation can be obtained. Forinstance, the gate or injection port within the injection mold can beadapted to orient the molecules by the shear stresses that are impartedto the polymeric melt when the injection mold cavity is being filled. Asmaller gate can provide a high shear stress and result in high polymermolecule orientation. A cross-sectional length, such as a diameter, ofthis small gate can be from about 10% to about 60% of the cavity averagecross-sectional length (diameter) or runner cross-sectional length(diameter) to provide optimal polymer orientation. In otherconfigurations, the cross-sectional length of the small gate can be fromabout 12% to about 25%, or from about 15% to about 20%. In still otherconfigurations the small gate diameter or cross-sectional length canrange from about 20% to about 50% or from about 30% to about 40% of themold cavity average cross-sectional length (diameter) or runnercross-sectional length (diameter).

Through optimizing the level of polymeric molecule orientation, theinjection molding system can impart mechanical stability to the fastener10 (FIG. 1), while creating the properties that allow the fastener 10(FIG. 1) to foreshorten and swell overtime. By optimizing the injectionmolding conditions (e.g., polymer composition, mold configuration,polymer melt temperature, flow rates, gate configuration, shear stress,etc.), the process can provide the fastener that when implanted in apatient will securely mount to the bone of a patient as it shortens inlength and swells in width during the time that the bone changes itsstructure because of the stress applied by the fastener 10 (FIG. 1).

Turning to FIG. 2, is a schematic diagram illustrating an embodiment ofthe injection molding system 50 in accordance with the presentinvention. In general, the injection molding system 50 can be configuredto yield an implantable fastener to secure bone or mount a plate tostructurally reinforce bone. The injection molding system 50 can includea mixer 52 configured to receive polymeric materials, such asbiodegradable and/or inert polymeric materials, in order to form asubstantially homogenous polymeric composition. Additionally, the mixer52 can be configured to receive other types of polymeric materials,plasticizers, rheology-modifying agents, fillers, and the like in orderto provide various other characteristics to the fastener 10 (FIG. 1)fabricated with the injection molding system 50.

Optionally, the injection molding system 50 can include an extruder 54.As such, the polymeric composition mixed and formulated within the mixer52 can be supplied into the extruder 54 for further mixing, compacting,heating, and/or extruding. The extruder 54 can be a single screwextruder, double screw extruder, or piston-type extruder. Additionally,the extruder 54 can include heating elements in order to take advantageof the thermoplastic characteristics of some embodiments of thepolymeric composition and heat the composition past its softening point,melting point, and/or glass-transition temperature. In any event, theextruder 54 can extrude the composition through a die head to anextrudate of any shape, which can optionally be pelleted beforeinjection molding.

After being extruded from the extruder 54 or mixed within the mixer 52,the polymeric composition can be introduced into a pre-mold 60. Thepre-mold 60 can be a compartment, container, tube, conduit, injectionline, or the like in fluid communication with the injection mold 62 thatcan hold the polymeric material before being injection molded.Alternatively, the composition can be provided directly into theinjection mold 62 from the extruder 54 or mixer 52.

Additionally, a dryer 16 can dry the polymeric material while in thepre-mold 20. Sometime the polymeric material can absorb moisture duringprocessing, wherein the moisture can be counter-effective to a resultingplate; especially when a biodegradable polymer, which can cause theplate to prematurely degrade. As such, the dryer 16 can be configured toremove moisture from the polymeric material.

Additionally, a pressurizer 18 can pressurize the pre-mold 20 so thatpolymeric composition can be injected into the injection mold 22 underhigh pressure. For example, the injection molding process can beperformed at about 10 atm to about 2500 atm or from about 100 atm toabout 1500 atm.

The heater 56 and the pressurizer 58 may be optional because thepre-mold 60 and/or the injection mold 62 may be outfitted with suchcomponents or otherwise provide these functionalities. In addition tothe above, other well-known injection molding equipment may be utilizedin conjunction with the pre-mold 60 so as to prepare the polymericcomposition for injection molding.

Following heating in the pre-mold 60, the polymeric composition can beinjected into the injection mold 62 in order to form the fastener 10(FIG. 1). For instance, the polymeric composition can be injected into amaster mold within a cavity of the injection mold 62, the master moldhaving one or more cavities that define the configuration of thefastener 10 (FIG. 1). Usually, the process includes injecting thepolymeric composition under high pressure and/or heat so that thecomposition can flow through the various pathways and compartmentswithin the injection mold 62 until it reaches the cavities that definethe fastener 10 (FIG. 1).

In the described configuration of the injection molding system 50, themaster mold of the injection mold 62 can be cooled by water, air, orfluid flowing through conduits in the master mold or other portions ofthe injection molding system 50. In this manner, the polymericcomposition can be cooled quickly following injection into the mastermold so that the orientation of the polymer macromolecules can be fixedand prevented from changing during the molding process.

While general features of the injection molding system 50 have beendescribed in connection with injection molding, various other processesor techniques can be utilized in order to prepare the fastener 10(FIG. 1) in accordance with the present invention.

Turning to FIG. 3, illustrated is one half of a master mold, identifiedby reference numeral 70. The following discussion will be directed tothe illustrated half, but it will be understood that the discussion alsoapplies to the other half of the master mold since it will havegenerally a similar or complementary configuration and function. Asshown, the master mold 70 has a generally octagonal configuration with acold runner 74 disposed at its center 72. Spaced around the center 72are individual sub-molds 76 a-76 h that define the configuration of thefastener 10 to be formed using the injection molding system 50 (FIG. 3).Each sub-mold 76 a-76 h can include a cavity 78 a-78 h that defines theparticular configurations of the fastener moldable using that particularsub-mold. Although the illustrated master mold 70 is illustrated ashaving eight different sub-molds 76 a-76 h, it will be understood thatin other configurations any combination of sub-molds 76 a-76 h arepossible. For instance, the master mold 70 can include eight or lessthan eight of any one of the sub-molds 76 a-76 h.

The following discussion will be directed to the sub-mold 76 a. However,a similar discussion can be made with each of the other sub-molds 76b-76 h. As illustrated, the sub-mold 76 a includes the cavity 78 a thatcommunicates with the cold runner 74 by way of a channel 80. A taperedend 82 of the channel 80 provides the inlet to the cavity 78 a for thepolymer composition. This tapered end 82 acts as a gate having a smalldiameter to provide a high shear stress to the polymer composition thatresults in high polymer molecule orientation. Depending upon theparticular configuration of the fastener, the tapered end 82 can have across-sectional length (diameter) of from about 5% to about 30% of thecavity average cross-sectional length (diameter) or runnercross-sectional length (diameter) to provide optimal polymerorientation. In other configurations, the cross-sectional length(diameter) of the tapered end 82 can be from about 10% to about 25% orfrom about 15% to about 20% of the cavity average cross-sectional length(diameter) or runner cross-sectional length (diameter). More generally,the cross-sectional area of the tapered end 82 can be sufficiently sizedto highly orientate the polymer macromolecules, i.e., apply the level ofshear stress to the polymer composition to achieve high polymermolecular orientation. Examples of some cross-sectional shapes for thetapered end 82 can include circles, rectangles, squares, octagons,pentagons, and the like, wherein various polygons can be used in orderto provide the proper polymer molecule orientation.

Since the master mold 70 is cooled by water, air, or fluid surroundingand/or passing through conduits in the master mold 70, the high polymermolecule orientation is fixed or frozen during the injection moldingprocess. This results in the fasteners formed by the master mold 70having the desired high polymer molecule orientation that causes theshorting and swelling of the fastener in the patient's body and belowthe glass transition temperature.

It will be understood that the injection molding system 50 (FIG. 3)described herein is only one example of a possible injection moldingsystem that can be used to form the fasteners of the present invention.It can be understood that various other types of injection moldingsystem can be used. For instance, the injection molding system 50 (FIG.3) can include a two body, three body, or multi-body mold, and can beoperated with cold or hot runners. Additionally, various modificationscan be made to the exemplary mold described herein.

The present invention can also relate to a method of manufacturing thefastener having the features described in accordance with the presentinvention. Such a method of manufacturing can employ the foregoingcompositions, equipment, systems, and processes as previously described.An exemplary method of manufacturing is described in more detail below.

FIG. 4 illustrates an embodiment of an implantable fastener fabricationmethod 100. Such a fastener fabrication method 100 can include andutilize any of the equipment, components, and processes described inconnection to FIG. 1 through FIG. 3 and otherwise know to those in theinjection molding art. Accordingly, the fastener fabrication method 100includes preparing a polymer to have the thermoplastic characteristicsand resulting fastener strength and flexibility profiles as describedabove, as represented by block 102. By preparing the polymer compositionto have the proper components and concentrations, the implantablefastener can be prepared to have the preferred foreshortening, swelling,and structural features.

In one embodiment, the polymer composition can be extruded, asrepresented by block 104. Extruding the polymer composition can bebeneficial in order to provide the proper configuration, consistency,temperature, and the like before injection molding. This can includefurther mixing and/or compaction of the polymeric materials as well asheating the polymer past its softening point, melting point, and/orglass transition temperature.

In any event, the polymer can be supplied into a polymer pre-mold, asrepresented by block 106. Within the pre-mold, the polymer compositioncan be pressurized so as to have the proper pressure for being injectedinto the injection mold, as represented by block 108. Additionally, thepolymer composition can be dried in the pre-mold to remove moisture asneeded, as represented by block 110.

After being properly conditioned, the polymer composition can beintroduced into the injection mold, such as the master mold, forinjection molding, as represented by block 112. The polymer molecules inthe composition can be oriented by the tapered end 82 (FIG. 3) of thechannel 80 leading to the cavity 78 of the master mold 70 to achieve adesired amount of orientation, as represented by block 114. Theinjection molded body can then be removed from the mold and cooled, asrepresented by block 116, and the fastener subsequently separated fromthe polymeric runners or other polymeric features, as represented byblock 118. More specifically, when the molded body is formed, whichtypically includes molded runners, vents, dividers, cold wells, andplate regions, the fastener can be separated from the other features. Inany event, the separation can be performed by cutting, pressing,stamping, or otherwise removing the polymer features from the plates.

Moreover, after the fastener has been separated from other polymericfeatures, the fastener can be finished, as represented by block 120.Finishing can include grinding, surfacing, sanding or otherwise removinganomalies or other surface features on the fastener. Also, the finishingcan include providing a coating to the molded fastener, if desired.Additionally, any other well-known process for finishing a moldedarticle can be used in connection herewith in order to substantiallyfinish the fastener into a useable and implantable condition. However,the fastener can be ready for use after injection molding without anyfurther finishing.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

1. A method of manufacturing an implantable fastener, the method comprising: injection molding a biocompatible polymeric composition into a polymeric body within an injection mold cavity, wherein at least a portion of said polymeric body is configured to be an implantable fastener; and removing said polymeric body from said injection mold, wherein said polymeric body has an amount of polymeric molecules oriented in substantially a first direction so that said polymeric body foreshortens and swells upon being introduced into a moist environment having a temperature below a glass transition temperature of the biocompatible polymeric composition.
 2. The method as recited in claim 1, wherein said injection molding comprises passing said polymeric composition through an inlet in a master mold that is configured to orientate macromolecules of the biocompatible polymeric composition in substantially a first direction.
 3. The method as recited in claim 1, wherein said injection molding comprises passing said polymeric composition through an inlet into said injection mold cavity, said inlet imparting a shear stress to said polymeric composition to orientate macromolecules of said biocompatible polymeric composition in substantially a first direction generally parallel to a longitudinal axis of said polymeric body.
 4. The method as recited in claim 3, wherein said inlet has a cross-sectional length from about 10% to about 60% of an average cross-sectional length of said injection mold cavity or a runner.
 5. The method as recited in claim 3, wherein said inlet has a cross-sectional length from about 20% to about 50% of an average cross-sectional length of said injection mold cavity or a runner.
 6. The method as recited in claim 3, wherein said inlet has a cross-sectional length from about 30% to about 40% of an average cross-sectional length of said injection mold cavity or a runner.
 7. The method as recited in claim 1, further comprising orienting the polymeric molecules so that said implantable fastener foreshortens greater than about 2% of an original dimension in 10 days when maintained in a fluid at 37 degrees Celsius.
 8. The method as recited in claim 1, wherein said implantable fastener is biodegradable within a fluid medium maintained at 37 degrees Celsius.
 9. The method as recited in claim 1, selecting a master mold and one or more sub-molds, each of said one or more sub-molds comprising said injection mold cavity.
 10. The method as recited in claim 1, wherein the biocompatible polymeric composition is a biodegradable polymeric composition.
 11. The method as recited in claim 10, wherein the biodegradable polymeric composition is comprised of at least one polymer selected from the group consisting of a poly(alpha-hydroxy esters), polylactic acids, polylactides, poly-L-lactide, poly-DL-lactide, poly-L-lactide-co-DL-lacti-de, polyglycolic acids, polyglycolide, polylactic-co-glycolic acids, polyglycolide-co-lactide, polyglycolide-co-DL-lactide, polyglycolide-co-L-lactide, polyanhydrides, polyanhydride-co-imides, polyesters, polyorthoesters, polycaprolactones, polyesters, polyanydrides, polyphosphazenes, polyester amides, polyester urethanes, polycarbonates, polytrimethylene carbonates, polyglycolide-co-trimethylen-e carbonates, poly(PBA-carbonates), polyfumarates, polypropylene fumarate, poly(p-dioxanone), polyhydroxyalkanoates, polyamino acids, poly-L-tyrosines, poly(beta-hydroxybutyrate), polyhydroxybutyrate-hydroxyvaler-is acids, high-density polyethylenes, ultra-high-density polyethylenes, low-density polyethylenes, polypropylenes, polyacrylates, polymethylmethacrylates, polyethylmethacrylates, polysulfones, polyetheretherketones, polytetrafluoroethylenes, polyurethanes, polystyrenes, polystyrene-co-butadienes, and combinations thereof.
 12. The method as in claim 11, wherein the biodegradable polymeric composition is comprised of at least one polymer selected from the group consisting of polylactides, poly-L-lactide, poly-DL-lactide, poly-L-lactide-co-DL-lactide, polyglycolic acids, polyglycolide, polylactic-co-glycolic acids, polyglycolide-lactide, polyglycolide-co-DL-lactide, polyglycolide-co-L-lactide, and combinations thereof.
 13. The method as recited in claim 1, further comprising at least one of: mixing said polymeric composition in a mixer; extruding said polymeric composition as a thermoplastic extrudate; heating said polymeric composition before being introduced into said injection mold cavity; introducing said polymeric composition into said injection mold cavity under pressure; cooling said polymeric body in said injection mold cavity; separating said implantable fastener form said polymeric body; or finishing said implantable fastener. 